CED Role in Linking Global HT Innovation and Standards:

From the Research Lab to the BedsideWednesday, May 10, 9:45 am

Yadin David, Ed.D., P.E., C.C.E, FAIMBE, FACCE - Biomedical Engineering Consultants, LLC, USA

Fred Hosea, Ph.D. – Visiting Professor, Yachay Tech University, Ecuador

Tom Judd, M.S., CCE, CPHQ, CPHIMS, FACCE, FHIMSS - IFMBE Clinical Engineering Division Secretary, USA

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Disclosure

•The presenters declare no conflict of interest with the materials provided; they have received no funding for any projects described.

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Greetings from the Largest Medical Center & Space Center

In Houston, Texas, USA

Outline

• Identifying the total Health Technology Life-cycle • Product commercialization process from ideation

phase to Bedside• How can we improve new products introduction & use• Integrating the front end with the back end• Summary

Healthcare Delivery Industry is Changing & Growing

Technology Life Cycle

• Concept• Pre clinical• Clinical trials

• Manufacturing• Marketing

• Commercial use• Upgrades• Obsolescence/Retirement

What can we improve upon?Integrating the upfront quality system

management with lessons learned form adverse events at the backend of the cycle

Adverse events reporting

Product Development: “Waterfall” Model CE Role in Design Control

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070627.htm#_Toc382720785

Create prototype

TRIAD Catheter SystemEngineering Delivery Solutions for Medical Applications

Clinical trials role?

Lessons learned

3 Big Picture Strategies in Healthcare Innovation

The Global Health Innovation Registry The Continental Innovation Network A Global Design Cooperative

Key Concepts in Healthcare Innovation• No single organization

in the world –including the nation-state – is adequately prepared to manage the constant and growing flood of healthcare innovations.

• The poorly-managed complexity of innovations is costly, wasteful, disruptive, and unnecessary

• No single, unified data resource exists to align efforts and promote convergent design of healthcare innovations

• Collaboration among institutions and professions should become the new business model for promoting CONVERGENT INNOVATION

• Managing the challenges of the lifecycle of healthcare systems exceeds the current capacities of any country in the world, and the difficulties are only growing. Some central problems are: Unprecedented technical complexity Demand for universal services and new service lines Interdependence and interoperability of systems Global economic slowdown, without likelihood of recovering previous growth rates Velocity of change Obsolete, inadequate infrastructures Fragmentary market mechanisms and perverse incentives Political and economic interests that preserve a dysfunctional status quo Obsolete professional and organizational structures Disjointed incrementalism; horizontal integration of vertical expertises is lacking Demographic pressures that exceed current and future capacity Predicted, RADICAL impacts of climate change: migration of populations, infectious diseases;

and economic refugees to unprepared locations

A new age of integrated innovation is essential to achieve the possibilities of Health for All. New forms of collaboration and interdisciplinary knowledge will be necessary to fill in the

gaps. The concept of innovation must be adjusted to include more innovations that effectively

integrate stakeholder and lifecycle requirements AT THE DESIGN STAGE, instead of creating a relentless treadmill of expensive high-tech point solutions that often promise more than they deliver.

National innovation centers will serve as hemispheric resources in their areas of investigation, prototyping and best practices (e.g., telemedicine, tropical diseases, disaster management, etc.), and will serve as consultation centers to all other countries in the network, providing expertise organized along the entire lifecycle of successful innovation.

It’s time for Convergent Innovation

WHOLE-SYSTEMS VIEW OF INNOVATION - Depending on the industry or agency involved, many innovations have a piecemeal quality, often defined by narrow views of the problem or market opportunity being addressed, or by short timeframes driven by market cycles, by random changes in personnel or organizational leadership, or by a technological discovery that is over-hyped in order to get a lead over competitors. Convergent Innovation fosters a comprehensive view of all essential dimensions of design, not just technological, consumer or economic ones. Comprehensive stakeholder research (interviews, focus groups, surveys) will be necessary to evaluate and include all appropriate stakeholder requirements. at the design stage.

EXPANDED DESIGN SCOPE and processes for innovations to encompass the entire lifecycle of the innovation and the multiple impacts it has on all stakeholders and the environment.

END-TO-END DESIGN INTELLIGENCE – Horizontal expertise that spans the entire lifecycle of an innovation and the systems it impacts, to coordinate and synergize the numerous areas of vertical expertise that often lead to disjointed point solutions that don’t integrate well with other system functions.

COLLABORATIVE DESIGN FORUMS to engage key stakeholders at the trans-national level of strategy and planning

NON-PROFIT INTER-SECTORAL ALLIANCES to solve core technology challenges (e.g., The Continua Alliance)

STRATIFIED INNOVATION GOALS to re-target manufacturing, facilities and workforces more equitably toward low and medium resource markets, with more local production.

STRATEGIC CONSULTATIONS across Ministries of Health, academic centers and industry laisons to develop and align mid- to long-term infrastructure plans and capital budgets, within regional and multi-national planning and purchasing frameworks

COORDINATED ACADEMIC PARTNERSHIPS to cultivate sustained, multi-disciplinary research and professional development programs aimed at integrated healthcare planning

REGIONAL/CONTINENTAL NETWORKS OF INNOVATION CENTERS to distribute the enormous workload of innovation design, assessment, testing and planning

“DESIGN FOR CASCADE” – design of higher-cost systems and supply-chain logistics for staged re-use in low-resource locations

Adoption of COMMON INTEROPERABILITY MATURITY roadmaps that enable coordinated staging of medical devices with IT systems and evolving clinical treatment practices.

“Convergent Innovation” is proposed as a healthcare innovation model that will leverage medical technology and service innovations more effectively to achieve a higher adoption rate of appropriate and interoperable technologies with less wastage of resources, less planned obsolescence, more universal coverage, lower cost, and a more rational staging of medical infrastructures as economies and service models mature. We need to cultivate:

The Global Health Innovation RegistryIn partnership with global health organizations, industry and academia, develop a GLOBAL HEALTH INNOVATION REGISTRY, using a semantic web/ data lake platform to enable rapidly searchable integration of separate relational databases, worldwide. Innovators register their innovation with whatever degree of detail and specificity they prefer, consistent with their collaborative or competitive orientations.

Criteria for Prioritization• Unmet health needs• Convergent innovation• Local production• Community health workers• Low regulatory hurdles

Semantic data lake platform

Outcomes• Baseline capability for

future grants• New data strategy

beyond disjointed legacy systems

• Weekly-/monthly Innovation Forums with MoHs to educate, inspire, and create collaborations

• Rapid Evaluation consultation teams

• More efficient targeting of innovations

• Capacity-building for innovators using System-lifecycle design principles

• Foundation for ICEHTMC 2017, São Paulo

GOALS• Identify & outreach to global

innovation community• Design and launch Innovation

Registry and global partner network

• Create visibility, catalytic leadership role with global innovation community

• Prototype design, use of semantic web platform to link disparate relational dbs and accelerate search capabilities

• Create innovation ontologies to supplment existing standards

• Leverage a mixed model for Intellectual Property

• Coordinate with Continental Innovation Network initiatives

• Focus initially on a common, but complex innovation challenge

• Methodology to plot innovations on Gartner-like quadrants

Continental Innovation NetworksKey Concepts of Proposal

• The full spectrum of innovation challenges exceeds national institutional capabilities

• The burden of managing innovations should be spread out across a continental network of Centers of Excellence (CoE)

• Each CoE would be the design expert, coordinating hub and consulting center for the continent

• Each country could develop at least one CoE, depending on its resources

• As a hub, each CoE would work closely with academic , industry, and government entities to pool expertise and organize R&D collaborations

• Each CoE hub will have liaisons to other global specialty centers, such as WHO Collaborating Centers.

• CoEs will operate on basis of convergent innovation principles

• Continental strategies will leverage purchasing power to lower costs

Design Challenge: Point-of-care Detection of Heavy Metal Exposure in Humans

Hundreds of millions of people worldwide live in countries that have depended for centuries on extensive mining and petroleum production as central elements of the national economy. These often unregulated/un-monitored/un-enforced industries and renegade polluters have produced substantial human and environmental exposure to heavy metals (principally lead, cadmium, mercury, arsenic, mercury, chromium, cobalt, nickel, zinc, selenium, silver, antinomy and thallium) which can have significant adverse impacts on fetal and child development and public health along the human lifecycle, depending on timing and level of exposure.

Health impacts of heavy metals (HMs) can be profound: permanent neurological damage affecting fetal development and intellectualdevelopment of children, lung cancer, bone deterioration and fragility, skin cancer, skin deformities and lesions, vomiting, abdominal cramps, diarrhea, eye irritation, hair loss, nail brittleness, difficulties in breathing, increased or decreased blood pressure, numbness around the face, muscle weakness, high blood pressure, changes in heart rhythm or paralysis, irritation to the lining of the nose, nose ulcers, runny nose, asthma, cough, shortness of breath, wheezing, damage to liver, kidney circulatory and nerve tissues, brain damage, miscarriage, reproductive organ damage, irritability, shyness, tremors, changes in vision or hearing, memory problems, neurological abnormalities, and death.

This initiative seeks support for a multi-national, interdisciplinary research project to develop medical devices and an end-to-end service model that can be used to diagnose human exposure toheavy metals in a timely and cost-effective manner, using point-of-care devices that can be inexpensively produced within a cooperative regional consortium, and can operate in low-resource settings, without dependency on expensive, high-tech infrastructure, complex training, transportation or disruptive supply-chain vulnerabilities. Diagnostic results will be self-evident to the user via simple color displays, and may also indicate the need for additional consultation with a regional telemedicine center for additional analysis and professional medical consultation.

Next Steps? – join the Quest!

Contact Fred Hoseafhosea@yachaytech.edu.ecSkype: tangofred

• Think Big!• Sign up!• Join a work team• Share skills and ideas• Help develop the

innovation ontology• Recruit collaborators• Recruit liaisons from

Ministries of Health and Research Centers

• Enlist supporters with technical skills in Semantic Web programming

Innovation Case StudiesHT Life Cycle Management (aka HTM)

• Macedonia Maternal & Child (MCH) ‘Evidence-Based Medicine’ (EBM) Health HT• Minister of Health 2015 MCH Assessment, Follow-up, and Investment: Improve MoH NICU• Coordinated MoH HTM missing so far

• Haiti MCH EBM Health Technologies (HT)• Public Private Partnership Assessment, Follow-up, and Investment: Improve Country-Wide MCH• HTM A Work in Process; a lot of private HTM capacity available but no central coordination

• China Primary Care EBM HT• Government wants HT and related reform to improve care outcomes and cost• Private assessment pointed to Innovation … but not yet implemented in face of many challenges• Improve Primary Care and Links with Secondary Care• Strong HTM capability available locally and country-wide

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Summary1. The Healthcare market is in an excellent state for improving innovation’s outcomes.2. Increasing successful outcomes depends on a plan having input from an innovation

registry, assessment processes, well- structured life-cycle vision that incorporates lessons from unintended events and focused population-based HT solutions.

3. A Regional Life-cycle registry of adverse events is critical for improving the results of the use of new health technology that has been adopted to solve existing problems.

4. The path of innovation from research lab to the bedside must avoid known risks and ensure appropriate introduction including early validation of the science.

5. Understand challenges of regulatory compliance, adjust your timeline and funding accordingly (i.e., clinical trials).

6. Carefully review funding alternatives and have plan for controlling development costs.7. Ensure to included representation of all stakeholders that will be impacted.8. Select an advisory board with background in your product’s field to help guide your

commercialization process.9. There are many success stories…but, failures are also a reality. Be prepared.10. Mostly, it’s a team effort –

validated idea + good team + Lessons learned = SUCCESS!Enjoy it.